Editor-in-Chief's MESSAGE Welcome to the MRx Pipeline. This quarterly publication offers clinical insights and competitive intelligence on anticipated drugs in development, so you are well-sourced on the drug pipeline. MRx Pipeline, our universal forecast, addresses trends applicable across market segments. Traditional and specialty drugs as well as agents under the pharmacy and medical benefits are featured. Also profiled in the report are new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars. Clinical analyses, financial outlook, and pre-regulatory status are considered. The products housed in the MRx Pipeline have been researched in detail. They have been developed in consultation with our internal team of clinical and analytics experts.
METHODOLOGY
Emerging therapeutics continue to grow and influence the clinical and financial landscape. Therefore, Magellan Rx Management has developed a systematic approach to determine the products with significant clinical impact. For the in-depth clinical evaluations, the products’ potential to meet an underserved need in the market by becoming the new standard of care, and the ability to replace existing therapies were investigated. The extent to which the pipeline drugs could shift market share on a formulary and their impact on disease prevalence were also important considerations. In order to assist payers with assessing the potential impact of these pipeline drugs, where available, a financial forecast has been included for select products. Primarily complemented by data from EvaluateTM, this pipeline report looks ahead at the 5-year projected annual US sales through the year 2025. These figures are not specific to a particular commercial or government line of business; rather, they look at forecasted total US sales. Depending on a variety of factors, including the therapeutic categories, eventual FDA-approved indications, populations within the plan, and other indices, the financial impact could vary by different lines of business.
LOOKING BACK
Despite the pandemic's unprecedented challenges, in 2020, the US FDA approved 53 novel drugs, making it the second highest number of approvals in 10 years. Notably, 58% of these approvals were for patients with Orphan conditions. Of note, the all-time record approvals was in 2018 with 59 novel drugs approved. Furthermore, the last 3 years share the distinction of having the highest number of approvals in the last 10 years. Remarkably, in late 2020, two life-saving COVID-19 vaccines received Emergency Use Authorization (EUA). While numbers do not tell the entire story, they do represent incredible advances in patient care and hope for the American public.
ON THE HORIZON
As we look ahead, there is a continued trend toward the approval of specialty medications and drugs for rare and ultra rare diseases, with 61% and 34% of approvals expected, respectively, for agents with applications submitted to the FDA. The growth of biosimilars, new treatment modalities using gene therapy, and additional CAR T therapies are expected. A public health arsenal of COVID-19 therapeutics and vaccines, including a single-dose shot, will make 2021 a pivotal year in combating this deadly infection. Other noteworthy pipeline trends to watch include the development of complex therapies, oncology, immunology, therapeutic options for rare hereditary diseases, and a possible new therapy for Alzheimer’s disease. Moreover, sprouting products for hematology, ophthalmology, and diabetes await on the horizon. The drug pipeline ecosphere will continue to evolve as it faces challenges and successes. Innovative agents that show positive results without compromising patient safety and access offer true therapeutic advances and hold the promise to alter the treatment paradigm. Maryam Tabatabai, PharmD Editor-in-Chief, MRx Pipeline
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